DiabetesNCT00797771
User Satisfaction Using the ADI Insulin Pump
A study testing "Adi" Insulin pump in people with Diabetes, run by NiliMedix at 1 site in Israel.
Trial summary
Approximately 250,000 people worldwide are currently being treated with an insulin pump. This number is growing dramatically as these devices become smaller and more user-friendly. Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing the number of hypoglycemic events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- "Adi" Insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female age 18 years and up.
- Subject is diagnosed as Type 1 Diabetes.
- Pump Users for at least 6 months
- HbA1c: less than 8.5%
- Capable of reading pump screens in English.
- Subject understands the study procedure.
- Subject is willing to sign the informed consent form and comply with the study requirements.
Who cannot join
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Subject experienced a severe hypoglycemic episode that led to hospitalization during the last 6 months.
- Subject experienced an episode of Ketoacidosis during the last 6 months, while using an insulin pump.
- Concurrent additional major illness.
- Subject objects to the study protocol.
- Physician objection
- Concurrent participation in other study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of User Satisfaction Using the ADI Insulin Pump
Approximately 250,000 people worldwide are currently being treated with an insulin pump. This number is growing dramatically as these devices become smaller and more user-friendly. Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing the number of hypoglycemic events.
The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro- infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the pressure of insulin within it to deliver preset basal profiles and patient programmed bolus of insulin through custom infusion sets, into subcutaneous tissue.
This type of device requires extensive user interaction and education in order to ensure its safety. This study was designed to test the independent home-use of the NiliMedix ADI Insulin Pump, and to evaluate user's satisfaction.
- Conditions
- Diabetes
- Being tested
- "Adi" Insulin pump
- Keywords
- Insulin delivery
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Adi" Insulin pumpDevice
insulin delivery will be defined by the physician
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | "Adi" insulin pump users Receives: Device: "Adi" Insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
User satisfaction regarding the "Adi" pump functioning will be evaluated by questionnaire. The questionnaire will be administrated during the last study visit
Measured: End of study
Secondary outcomes (1)
Number of severe hypoglycemic events
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NiliMedix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shlomit Shalitin, MD, Principal investigator, Schnieder Children's Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797771
- Sponsor's protocol ID
- NM-HU-01
- Status last verified
- Jun 2009
- First submitted
- 23 Nov 2008
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of User Satisfaction Using the ADI Insulin Pump
- ClinicalTrials.gov ID
- NCT00797771
- Acronym / sponsor ID
- NM-HU-01
- Conditions
- Diabetes
- Keywords
- Insulin delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NiliMedixIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 250,000 people worldwide are currently being treated with an insulin pump. This number is growing dramatically as these devices become smaller and more user-friendly. Insulin pumps allow for tight metabolic control and lifestyle flexibility while minimizing the number of hypoglycemic events.
The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro- infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the pressure of insulin within it to deliver preset basal profiles and patient programmed bolus of insulin through custom infusion sets, into subcutaneous tissue.
This type of device requires extensive user interaction and education in order to ensure its safety. This study was designed to test the independent home-use of the NiliMedix ADI Insulin Pump, and to evaluate user's satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: "Adi" Insulin pump"Adi" insulin pump users |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male/female age 18 years and up.
- Subject is diagnosed as Type 1 Diabetes.
- Pump Users for at least 6 months
- HbA1c: less than 8.5%
- Capable of reading pump screens in English.
Key exclusion criteria (7 listed)
- Major physical, motor, mental, behavioral, or psychiatric limitations.
- Subject experienced a severe hypoglycemic episode that led to hospitalization during the last 6 months.
- Subject experienced an episode of Ketoacidosis during the last 6 months, while using an insulin pump.
- Concurrent additional major illness.
- Subject objects to the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Adi" Insulin pumpinsulin delivery will be defined by the physician | Device | A |
Primary outcome
User satisfaction regarding the "Adi" pump functioning will be evaluated by questionnaire. The questionnaire will be administrated during the last study visit
Time frame: End of study
1 secondary outcome
Number of severe hypoglycemic events
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomit Shalitin, MD principal investigator
Schnieder Children's Medical Center Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Adi" Insulin pump in people with Diabetes, run by NiliMedix at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User satisfaction regarding the "Adi" pump functioning will be evaluated by questionnaire. The questionnaire will be administrated during the last study visit (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011.